Heart valves are sometimes damaged by disease or by aging, resulting in problems with the proper functioning of the valve. Heart valve replacement has become a routine surgical procedure for patients suffering from valve dysfunctions. Traditional open surgery inflicts significant patient trauma and discomfort, requires extensive recuperation times, and may result in life-threatening complications.
To address these concerns, efforts have been made to perform cardiac valve replacements using minimally-invasive techniques. In these methods, laparoscopic instruments are employed to make small openings through the patient's ribs to provide access to the heart. While considerable effort has been devoted to such techniques, widespread acceptance has been limited by the clinician's ability to access only certain regions of the heart using laparoscopic instruments.
Still other efforts have been focused upon percutaneous transcatheter (or transluminal) delivery of replacement cardiac valves to solve the problems presented by traditional open surgery and minimally-invasive surgical methods. In such methods, a valve prosthesis is compacted for delivery in a catheter and then advanced, for example through an opening in the femoral artery and through the descending aorta to the heart, where the prosthesis is then deployed in the valve annulus (e.g., the aortic valve annulus).
Valve prostheses are generally formed by attaching a bioprosthetic valve to a frame made of a wire or a network of wires. Such a valve prosthesis can be contracted radially to introduce the valve prosthesis into the body of the patient percutaneously through a catheter. The valve prosthesis can be deployed by radially expanding it once positioned at the desired target site.
To prepare such a valve prosthesis for implantation, the valve prosthesis can be initially provided in an expanded or uncrimped condition, then crimped or compressed around the distal tip of the catheter assembly. Various methods and devices are available for crimping the valve prosthesis onto the catheter's distal tip, which may include hand-held devices or tabletop devices, for example. Due to the bioprosthetic valve, the valve prosthesis often is not shipped loaded into the delivery catheter. Instead, many transcatheter valve prostheses must be loaded into the catheter assembly by hand at the treatment facility (e.g., operating room, catheterization laboratory) immediately prior to performance of the procedure. Such transcatheter valve prostheses and their delivery catheters are often shipped in a medical device assembly tray, which may include a reservoir such that the valve prostheses may be loaded into the delivery catheter while submerged in a liquid solution in the reservoir. However, other medical devices, such as catheters used for devices other than heart valve prostheses, renal denervation devices, and other medical devices may also be shipped in medical device assembly trays.
The delivery catheter and/or medical device is regularly placed within the medical device assembly tray in a sterile environment. The tray is packaged within a sterile pouch, the pouch is sealed, and one, or both, of the pouch's ends are then folded against the medical device assembly tray. The folded pouch is placed within a shipping container for storage, transport, and delivery to treatment facilities. Unfortunately, the bulky tray designs can interact with the folds of the pouch, creating a risk to the sterile barrier integrity of the delivery catheter and/or medical device. Additionally, current tray designs are not ergonomically designed and the bulky trays are difficult to handle and manipulate.
Accordingly, there is a need for an improved tray design to protect these complex medical device assemblies.